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Clinical Trials/NCT03296748
NCT03296748CompletedPhase 2

Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?

Kasr El Aini Hospital2 sites in 1 country123 target enrollmentStarted: June 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
123
Locations
2
Primary Endpoint
Denovo urgency

Study Overview

Brief Summary

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Detailed Description

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
23 Years to 56 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • female patients
  • genuine stress incontinence
  • asymptomatic cystocele

Exclusion Criteria

  • mixed incontinence

Outcomes

Primary Outcomes

Denovo urgency

Time Frame: 3 months after surgery

by clinical assessment

cure rate of stress incontinence

Time Frame: 3 months after surgery

by clinical assessment

Secondary Outcomes

  • Denovo urgency(12 months after surgery)
  • cure rate of stress incontinence(12 months after surgery)

Investigators

Sponsor
Kasr El Aini Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

sarah mohamed hassan

lecturer of obstetrics and gynecology Cairo university

Kasr El Aini Hospital

Study Sites (2)

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